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Modern laser in situ keratomileusis outcomes – A review.

The LASIK industry has a long history of manipulating data and publishing junk science to protect the public perception of LASIK.

In 2009, leading LASIK surgeons published a literature review titled LASIK world literature review: quality of life and patient satisfaction1 which concluded that “95.4% of patients were satisfied with their outcome after LASIK surgery“. Nineteen articles were cited in the references as being the source of the data. What the manuscript fails to disclose is that a large percentage of these so-called “satisfied” patients reported complications such as bad night vision, night-time visual distortions, and dry eyes. The blog article at this link exposes the deception behind the 2009 literature review and reveals why you can’t believe anything these biased surgeons say.

The authors are well aware of the blog article which exposes the deception behind the 2009 literature review. So, in 2016 they tried again and published Modern laser in situ keratomileusis outcomes.2 Four of the co-authors on the 2009 review also co-authored the 2016 review — three of which are past presidents of the American Society of Cataract and Refractive Surgery (ASCRS), the largest U.S. professional society for surgeons who practice LASIK and other forms of unnecessary vision correction surgery. In the 2016 review, the authors withheld most of their sources, apparently to frustrate attempts by their critics to expose them again for publishing junk science. The authors state that they located 97 relevant articles in the literature search; however, the references contain only 17 citations, and it doesn’t appear that most of the 17 articles were part of the 97 articles retained for the analysis. In other words, they did not disclose their sources.

However, the authors made reference to the largest data-set (48% of total) in the review, which was a non-peer-reviewed article3 of one-month LASIK outcomes in low to moderate myopia at Optical Express, a large LASIK provider in the United Kingdom, by Steven Schallhorn, MD. The article was published in an Optical Express sponsored supplement to the Journal of Refractive Surgery. The source of the remaining 52% of the data is still a mystery. This begs two questions: what are they hiding, and how did this pass peer review?

Schallhorn is well-known for being a paid medical malpractice defense expert witness (testifying against injured LASIK patients), industry consultant, and medical director of Optical Express, making public statements and publishing literature denying connection between a poor LASIK outcome and diminished quality of life, and having financial interests in companies that manufacture LASIK devices.

Schallhorn’s article is not credible. For example, it cites an incidence of dry eyes at one month after LASIK of .18%. The paper doesn’t provide details as to how dry eyes were assessed. It says only that “common LASIK complications were observed“. LASIK surgeons know that this dry eye statistic is utter nonsense. In the ASCRS 2017 Clinical Survey, respondents said that LASIK significantly increased the level of dry eye at 6 months post-op in 22% of their patients.

In December 2016, a Dutch television program, Zembla, aired a documentary on LASIK. Zembla journalists interviewed Dr. Ton Rouwen, a LASIK surgeon and Secretary of the Dutch Society of Refractive Surgeons. Rouwen cited the 2016 review as evidence of the supposed success and safety of LASIK. Zembla filmmakers — aware of the controversy surrounding the review — contacted the authors of the review to question them about their sources, but their questions were not answered. Zembla then sent the paper to an expert at the Cochrane Institute who opined that it gave the impression of cherry-picking.

The 2016 review states, “Industry bias was not evident [in the sources]”. This statement is impossible to verify, as sources of 52% of the data were not disclosed. (It has already been established that Schallhorn — the source of 48% of the data — is heavily biased). However, industry bias is clearly evident in the review itself. One author, Richard Lindstrom, MD, was reported to have received nearly a million dollars in industry payments in 2016, the year of publication, by a U.S. federal government website. Eric Donnenfeld, MD, was reported to have received over $400K. Richard Potvin, OD, was reported to have received close to $200K. Kerry Solomon, MD, was reported to have received close to $100K. These figures don’t include profits from performing LASIK or other LASIK-related services. Five of the seven authors reported conflicts of interest in the very lengthy financial disclosures at the end of the manuscript.

The 2016 review also discloses support by the American Society of Cataract and Refractive Surgery and the American Refractive Surgery Council. These organizations are devoted to promoting LASIK and protecting the interests of LASIK surgeons.

The 2016 review further states, “An FDA panel meeting was held in 2008 in response to 140 dissatisfied LASIK patients to reevaluate the procedure.” At the time of publication in 2016, several thousand LASIK injuries had been reported to the FDA, not 140 — a fact that the authors conveniently fail to disclose.

Another excerpt from the review states, “In October 2009, the FDA instituted the LASIK Quality of Life Collaboration Project [which included a clinical study known as PROWL]… Industry and organized ophthalmology were not involved in the study design or the evaluation of data.” The latter statement is not true. The 2017 PROWL manuscript names three LASIK surgeons with conflicts of interest who served on the steering committee of the FDA LASIK study. Moreover, clinical investigators in PROWL also had conflicts of interest.

In summary, LASIK surgeons attempt to divert attention from the long-term consequences and widespread problems with LASIK by citing short-term patient satisfaction statistics from biased junk science. Forty-eight percent of the data in Modern laser in situ keratomileusis outcomes was taken from an article that was not peer-reviewed and is therefore unreliable. The remaining 52% of the data is from hidden sources. This is junk science published solely to promote LASIK. The authors and the peer-reviewers are not credible. The media should verify the veracity of the sources that representatives of the LASIK industry cite. ~~~

Side bar: A closer look at LASIK patient satisfaction.

One reason for the initial high rate of LASIK satisfaction is that patients are told that “side effects” (dry eyes, starbursts, halos, and double vision/ghost images) are temporary. So, although patients may be experiencing problems — such as dry eyes and night vision difficulties — they claim to be happy with the initial visual outcome while believing that so-called temporary side effects will resolve.

Cognitive dissonance is another reason for the initial high rate of satisfaction after LASIK. Patients who experience a less than optimal outcome have an internal conflict to resolve. Denying the problems is their way of coping. It’s easier psychologically than admitting to having made a bad, irreversible decision.

Another reason for reported satisfaction with LASIK is known as the Hawthorne effect, which states that patients may rate their level of satisfaction highly to please the surgeon.

An additional reason for the initial high rate of satisfaction with LASIK is this: When patients are contemplating undergoing LASIK, they may be due for an eye exam and new eyeglasses or contact lenses (virtually no one decides to get LASIK shortly after paying for a new pair of glasses). Because of this, they may not be seeing as clearly with their old eyeglasses or contact lenses prescription. So, when they have LASIK, it’s as if they updated their glasses and are suddenly seeing better than before. The difference is, with eyeglasses you can always get a new pair when your vision changes; but after LASIK, the outdated prescription is permanently lasered onto your corneas.

Dr. Edward Boshnick, a Florida optometrist who specializes in treating vision problems after laser eye surgery, estimates that roughly 80 percent of the failed LASIK cases that he treats were initially satisfied with their surgery but developed vision problems over time. He has treated hundreds of LASIK patients with post-LASIK corneal ectasia, a serious complication which may present many years after seemingly successful LASIK.